Topamax

Alert: Topamax Linked to Oral Birth Defects

Thomas J. Henry urge mothers who have used Topamax, or its generic topiramate, to contact an attorney as soon as possible if their child was born with any of the following birth defects: cleft lip and/or cleft palate. The FDA has issued a safety announcement due to new data from NAAED (North American Antiepileptic Drug Pregnancy Registry) indicating that expecting mothers who take the drug are around 20 times more likely to give birth to infants with cleft lips or cleft palate deformities than those who are not treated.

THE BACKGROUND OF TOPAMAX (TOPIRAMATE)

Since 1995, Topamax, manufactured by Ortho-McNeil-Janssen Pharmaceuticals, Inc., has been available worldwide for the treatment of epilepsy. The drug was also granted approval by the FDA to prevent migraines in August of 2004 and its generic form was approved by the FDA in April of 2009. More than 4 million patients have been treated with Topamax for migraines and epilepsy.

FDA ISSUES URGENT WARNING TO FEMALE TOPAMAX USERS

Today, March 4, 2011, the FDA strengthened the warning for patients using Topamax and it’s generic. Studies show that Topamax significantly increases oral birth defects, including cleft lip, and/or cleft palate in children whose mothers took Topamax during their pregnancy. In fact, this new data shows that expecting mothers who take the drug are 21.3 times more likely to give birth to infants with an oral birth defect such as cleft lips or palates compared to the risk in a background population of untreated women.

The FDA has sent out a notice to medical providers to warn their female patients about the risks of taking Topamax and to discuss alternative medications that have a lower risk of birth defects. Many developmental issues may occur in infants born with cleft palates or lips because they are not able to get adequate nutrition.

WHAT IS CLEFT PALATE AND CLEFT LIP?

Cleft lip and cleft palate range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and ear infections. Surgery is often used to close the lip and palate.